Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Based on the findings from four in vitro genotoxicity assays and an in vivo rat study for chromosome and DNA damage, Vinyl Neodeconoate is not mutagenic. The test substance did induce a statistically significant, does-related increase of the chromosome aberration frequency in CHO cells in culture when treatment was conducted in the presence of a rat liver derive S9 metabolic activation preparation. The increase of % aberrant cells was 17 -fold the vehicle control background level at the high concentration of 40 ug/mL. An In Vivo chromosome damage study is read across from vinyl neononanoate as a mouse micronucleus study.

Analysis of actual test data (phys/chem, environmental, mammalian, genotoxicity) indicates that the vinyl esters produce comparable effects or no effects at all. QSAR analysis supports the test results. This confirms that the ‘active’ function group in the esters produce the same effects (or no effects) and that the carbon difference in one of the alkyl chains does not significantly affect the toxicological properties of the vinyl esters.

We conclude that given the close similarity in the many endpoints available for comparison, the vinyl esters would also produce similar effects in other endpoint tests, and that the results can be “read-across”.

These vinyl esters meet the criteria for ‘read-across’ under the requirements of REACH Annex XI.1.5 and the guidance in Guidance R.6.

Justification for selection of genetic toxicity endpoint
As per REACH Annex VIII, Section 8.4.2. and ECHA Compliance Check Final Decision.

Short description of key information:
Vinyl Neodeconoate doses not induce gene-mutation in the Ames/Salmonella/E. coli bacterial mutation assay, in the yeast Saccharomyces cerevisiae and in the L5178Y Mouse Lymphoma assays. Vinyl Neodeconoate did not induce chromosome aberrations in rat liver derived RL4 cells in culture. Vinyl Neodeconoate did not induce DNA strand breaks or chromosome damage in vivo in a rat liver cell alkaline elution assay. The test substance was positive for the induction of chromosome aberrations in CHO cells when treatment was in the presence of rat liver S9 metabolic activation.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Vinyl Neodeconoate does not meet the criteria for Classification and Labeling as a mutagen as established by EU Directive 67/548/eec and the CLP.